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Freezing-dried preparation containing voriconazole and its preparation method

A voriconazole and drying technology, applied in the field of medicine, can solve problems such as no mention of voriconazole freeze-dried emulsion and the like

Inactive Publication Date: 2008-02-13
张文芳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] According to literature search, the patent related to the present invention is voriconazole preparation and its preparation method (200510068033.0), which mentions the preparation method of voriconazole emulsion, but does not mention voriconazole freeze-dried emulsion

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Voriconazole 100mg, oily component (soybean oil or medium chain oil or a mixture of both) 5g, α-tocopherol 50mg, oleic acid 0.5g, stearic acid monoglyceride 50mg, egg yolk lecithin 1.2g, maltose 10g, lactose 3g, appropriate amount of PH regulator

[0028] Preparation:

[0029] Weigh the prescribed amount of voriconazole, oleic acid, α-tocopherol and monoglyceride stearate, heat and dissolve in the oily component, stir at high speed to mix evenly, and make the oily phase;

[0030] Weigh the prescribed amount of lecithin, maltose and lactose, add the prescribed amount of water and stir at a high speed to fully disperse to form an aqueous phase.

[0031] Mix the two phases of oil and water, stir at 50°C-80°C at high speed to make colostrum, take the colostrum, dilute it with water for injection to the prescribed amount, adjust the pH value to 4.0-7.0, transfer it to a high-pressure homogenizer, and repeatedly emulsify to milk The average particle size of the droplets is ...

Embodiment 2

[0033] Voriconazole 500mg, oily component (soybean oil or medium chain oil or a mixture of both) 10g, α-tocopherol 200mg, oleic acid 1.0g, cholesterol oleate 100mg, soybean lecithin 2.5g, maltose 15g, sucrose 15g, Appropriate amount of PH regulator

[0034] Preparation:

[0035] Weigh the prescribed amount of voriconazole, oleic acid, α-tocopherol and cholesterol oleate, heat and dissolve in the oily component, stir at high speed to mix evenly, and make the oily phase;

[0036] Weigh the prescribed amount of lecithin, maltose and sucrose, add the prescribed amount of water and stir at a high speed to fully disperse to form an aqueous phase.

[0037] Mix the two phases of oil and water, stir at 50°C-80°C at high speed to make colostrum, take the colostrum, dilute it with water for injection to the prescribed amount, adjust the pH value to 4.0-7.0, transfer it to a high-pressure homogenizer, and repeatedly emulsify to milk The average particle size of the droplets is less than...

Embodiment 3

[0039] Voriconazole 1g, oily component (tea oil or medium chain oil or a mixture of both) 15g, α-tocopheryl succinate 500mg, oleic acid 1.5g, linoleic acid 1.0g, cholesterol nonanoate 200mg, egg yolk lecithin 4.0g, 20g maltose, 10g sucrose, 10g dextran, appropriate amount of pH regulator

[0040] Preparation:

[0041] Weigh the prescribed amount of voriconazole, oleic acid, α-tocopheryl succinate and cholesterol nonanoate, heat and dissolve in the oily component, stir at high speed to mix evenly, and make the oily phase;

[0042] Weigh the prescribed amount of lecithin, maltose, sucrose and dextran, add the prescribed amount of water and stir at a high speed to fully disperse to form an aqueous phase.

[0043] Mix the two phases of oil and water, stir at 50°C-80°C at high speed to make colostrum, take the colostrum, dilute it with water for injection to the prescribed amount, adjust the pH value to 4.0-7.0, transfer it to a high-pressure homogenizer, and repeatedly emulsify t...

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Abstract

The present invention discloses a voriconazole freezing dry preparation and the preparation method, which comprises the voriconazole, the oiliness component, the emulsifier and the freezing dry preparation. In the present invention, the voriconazole is packageed into the lipid micro sphere by the voriconazole freezing dry preparation. The melting speed is fast and the safety property is reliable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried preparation containing voriconazole and a preparation method thereof, which specifically comprises voriconazole, an oily component, an emulsifier and a freeze-drying support agent. Background technique [0002] Voriconazole chemical name: (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazole- 1-yl)-2-butanol, molecular formula: C16H14F3N5O, molecular weight: 349.3. [0003] Fungal infections in immunocompromised patients are associated with high morbidity and mortality, and those at greatest risk are those with severely compromised immune systems from cancer chemotherapy, bone marrow or organ transplantation, high-dose corticosteroid use, and AIDS. The number of patients at high risk for serious fungal infections is increasing, as are bone marrow and solid organ transplants and more aggressive chemotherapy. The mortality rate...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4745A61P31/18A61P31/10
Inventor 张文芳
Owner 张文芳
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